IYSC10 - Early Outcomes of a Novel Off-the-Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

Objectives: To investigate early outcomes of a novel off-the-shelf preloaded inner branched endograft (E-nside Jotec Gmbh, Hechingen, Germany) in the treatment of complex aortic pathologies.

Methods: We collected data from a physician-initiated national multicenter registry including patients treated with the E-nside endograft, an off-the-shelf inner branched endograft with preloaded catheters to facilitated branches cannulation. Preoperative clinical and anatomical data, procedural data, and early (30-days) outcomes were recorded in a dedicated electronic data capture system (REDcap-DCTV-Unipd). The primary endpoint was 30-days technical success (successful deployment of the device with no conversion or mortality and no type I or III endoleak; successful bridging, no bridging stent or graft limb occlusion). Secondary outcomes were procedural metrics and major adverse events (MAE).

Results: Seventy-nine consecutive patients from 26 Italian centers were collected. Mean age was 73±9 years and 53 (76%) were male. Aortic pathologies included degenerative aneurysm in 63 (80%), acute or subacute dissection in 2 (3%), pseudoaneurysm in 6 (8%), penetrating aortic ulcer in 3 (4%), intramural hematoma in 1 (1%), chronic dissection in 4 (5%). Mean aneurysm diameter was 68±18 mm; aneurysm extent was I-III in 33 (52%), type IV in 16 (25%), pararenal in 19 (30%), and juxtarenal in 3 (4%); a narrow aortic segment at the region of branches or visceral vessels (diameter between 20 and 30 mm) was present 15 patients (19%). The procedure setting was urgent in 19 (24%) patients.
The inner branches were cannulated from above in 67 (84%) cases, while the femoral accesses was used in 12 (16%). The main bridging stent was balloon-expandable in 246 (78%) target vessels and self-expandable in 66 (21%). Mean procedural time was 261±114 min, with a mean contrast volume of 183±153 ml and a radiation exposure of 5052±436 mGy*cm2.
Staged procedures were performed in 18 (22%) patients. Technical success at 30 days was 95% and mortality was 5% (n=4). MAEs were spinal cord ischemia in 5 (6%), stroke in 4 (5%), and myocardial infarction in 1 (1%). There were 6 (2%) target vessel-related events (5 occlusions and 1 type IC endoleak) and 1 type 1A endoleak needing reintervention.

Conclusions: In this real-world non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent and/or complex anatomies. Results shows excellent technical implantation safety and efficacy as also early outcomes; longer-term follow-up is needed to better define the clinical role of this novel endograft.